Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of the 364 participants screened for inclusion, 298 participants were excluded during screening and were not randomized. The remaining 66 participants met inclusion criteria and were randomly allocated to one of the two treatment sequences.

Reporting Groups

Description

Montelukast/ Placebo

In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.

Placebo/ Montelukast

In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Montelukast/ Placebo

In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.

Placebo/ Montelukast

In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.

Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose ]

Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Subsequent to a multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator may publish the results for their study site independently. However, the SPONSOR does not recommend separate publication of individual study site results. The SPONSOR must have the opportunity to review all proposed communications regarding this study 60 days prior to submission. Any information identified by the SPONSOR as confidential must be deleted.